Rx Only. NESS, NESS L300, Intelli-Gait, Intelli-Sense Gait Sensor, Bioness, the Bioness Logo and LiveOn are trademarks of Bioness Inc.

Transcription

1 Manufactured by Bioness Neuromodulation Ltd. A Bioness Inc Company 19 Ha Haroshet Street PO Box 2500 Industrial Zone Ra Anana 43654, Israel Worldwide Corporate Office Bioness Inc Rye Canyon Loop Valencia, CA USA Telephone: info@bioness.com Website: NESS, NESS L300, Intelli-Gait, Intelli-Sense Gait Sensor, Bioness, the Bioness Logo and LiveOn are trademarks of Bioness Inc. Rx Only Rev. F 01/2013

2 NESS L300 User s Guide

3 User s Guide Rx Only

4 User s Guide Copyright 2006, Revised 2012, Bioness Inc All Rights Reserved No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or translated into any language or any computer language, in any form or by any third party, without the prior written permission of Bioness Inc. Trademarks NESS, NESS L300, Intelli-Gait, Intelli-Sense Gait Sensor, Bioness, the Bioness Logo and LiveOn are trademarks of Bioness Inc. Patents Pending Aspects of this device are covered by several patents and patent applications including US Pat 7,899,556. Disclaimer Bioness Inc and its affiliates shall not be liable for any injury or damage suffered by any person, either directly or indirectly, as a result of the unauthorized use or repair of Bioness Inc products. Bioness Inc does not accept any responsibility for any damage caused to its products, either directly or indirectly, as a result of use and/or repair by unauthorized personnel. Environmental Policy Service personnel are advised that when changing any part of the NESS L300, care should be taken to dispose of those parts in the correct manner; where applicable, parts should be recycled. For more detailed information regarding these recommended procedures, please contact Bioness Inc. Bioness Inc is committed to continuously seeking and implementing the best possible manufacturing procedures and servicing routines. Conformity Certification Bioness Customer Support: Telephone: (800) , Option 2; or (661) , Option 2 Manufactured by Bioness Neuromodulation Ltd., A Bioness Inc Company 19 Ha Haroshet Street PO Box 2500 Industrial Zone Ra Anana 43654, Israel Worldwide Corporate Office Bioness Inc Rye Canyon Loop Valencia, CA USA Telephone: info@bioness.com Website: II

5 Contents List of Symbols... v Chapter 1: Introduction... 1 Chapter 2: Health and Safety Information... 3 Indications for Use... 3 Contraindications... 3 Warnings... 3 Precautions... 4 Adverse Reactions... 6 Skin Care Guidelines... 7 Chapter 3: Environmental Conditions that Affect Use... 9 Radio Frequency (RF) Communication... 9 Travel Chapter 4: NESS L300 System Kit Chapter 5: NESS L300 System Components Functional Stimulation (FS) Cuff Electrodes and Electrode Bases RF Stim Unit Intelli-Sense Gait Sensor Control Unit Control Unit Operating Buttons Control Unit Operating Modes Control Unit Digital Display and Indicator Lights Control Unit Audio Indicators Chapter 6: Setting Up the NESS L300 System Positioning the FS Cuff Removing the FS Cuff Positioning the Intelli-Sense Gait Sensor III

6 Chapter 7: Operating the NESS L RF Communication Safety Features Operating the Control Unit Turning On/Off the Control Unit Selecting an Operating Mode Adjusting Stimulation Intensity Adjusting the Volume of Audio Alerts Turning On Audio Feedback During Stimulation Chapter 8: Maintenance and Cleaning Charging the Batteries Replacing the Batteries RF Stim Unit Battery Intelli-Sense Gait Sensor Battery Control Unit Battery Replacing the L300 Quick Fit Electrodes Replacing the Cloth Electrodes Replacing the Hydrogel Electrodes Replacing the Electrode Bases Removing the RF Stim Unit Inserting the RF Stim Unit Cleaning Your NESS L300 Components Chapter 9: Electronically Registering New Components Registering a New Control Unit Registering a New RF Stim Unit Registering a New Intelli-Sense Gait Sensor Chapter 10: Troubleshooting Chapter 11: Technical Specifications Chapter 12: Appendix - EMI Tables IV

7 List of Symbols Caution Complies with United States and Canadian Product Safety Standards Complies with the European Union Medical Device Directive Serial Number Double Insulated (Equivalent to Class II of IEC 536) Type BF Applied Part(s) Non-Ionizing Radiation European Authorized Representative Date of Manufacture Manufacturer This Product Must not be Disposed of with Other Household Waste Consult Instructions for Use Re-Order Number Lot Number Certification of Radio Products for the Japanese Market V

8 VI

9 Introduction Central nervous system injuries often cause a gait disorder called foot drop. People who have foot drop are unable to raise their foot while walking. They often drag their foot, resulting in instability and increased effort during gait. 1 The NESS L300 Foot Drop System is an advanced neuroprosthesis designed to improve gait in people suffering from foot drop. The NESS L300 incorporates cutting-edge technology and sophisticated design features to improve walking and quality of life. Functional Stimulation Cuff with Radio Frequency Stim Unit Intelli-Sense Gait Sensor Regular L300 FS Cuff Small L300 FS Cuff Control Unit The NESS L300 consists of a Functional Stimulation (FS) Cuff (available in regular and small sizes) with a Radio Frequency (RF) Stim Unit, an Intelli- Sense Gait Sensor, and a Control Unit. These components communicate wirelessly to send electrical pulses to the peroneal nerve, which controls the muscles of the lower leg. When stimulated at the appropriate phase of walking, the muscles raise the foot, thereby preventing foot drop. Chapter 1 - Introduction 1

10 System Features: The FS Cuff includes a cradle for the RF Stim Unit and an advanced ergonomic locator to ensure constant, snug contact with the leg. The FS Cuff can be put on with one hand. The Intelli-Sense Gait Sensor can detect when the foot is in the air and on the ground and regulate stimulation appropriately. The wireless hand-held Control Unit monitors system status and manages system performance. Your clinician has prescribed the NESS L300 Foot Drop System to treat your foot drop. This User s Guide describes your NESS L300 Foot Drop System and how to operate your system to achieve maximum benefits. Be sure to read this guide before using your NESS L300. If you have any questions, consult your clinician or Bioness Inc immediately. 2 User s Guide

11 Health and Safety Information 2 Indications for Use The NESS L300 Foot Drop System is intended to provide ankle dorsiflexion in individuals (adults and pediatrics) who have foot drop following an upper motor neuron injury or disease. During the swing phase of gait, the NESS L300 electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot. The NESS L300 may improve gait, facilitate muscle re-education, prevent or retard disuse atrophy, maintain or increase joint range of motion, and increase local blood flow. Contraindications Patients with a demand-type cardiac pacemaker, defibrillator, or any electrical or metallic implant should not use the NESS L300. The NESS L300 should not be used where a cancerous lesion is present or suspected. The NESS L300 should not be used on a leg where a regional disorder, such as a fracture or dislocation, could be adversely affected by motion from the stimulation. The NESS L300 should not be used on a leg where strength testing or strength training is planned. Warnings The long-term effects of chronic electrical stimulation are unknown. The FS Cuff should not be worn over swollen, infected, or inflamed areas or skin eruptions, such as phlebitis, thrombophlebitis, and varicose veins. Chapter 2 - Health and Safety Information 3

12 Simultaneous connection of the NESS L300 to the patient and highfrequency surgical equipment may result in skin burns where the stimulator electrodes adhere and damage to the RF Stim Unit. Do not use the NESS L300 within three feet of short wave or microwave therapy equipment. Such equipment may produce instability in the RF Stim Unit output. The NESS L300 should only be configured by an authorized clinician. Precautions Inflammation in the region of the NESS L300 FS Cuff may be aggravated by motion, muscle activity, or pressure from the FS Cuff. Stop using the NESS L300 until the inflammation is gone. Use caution if you have a suspected or diagnosed heart problem. Use the FS Cuff with caution: If you have a tendency to hemorrhage following acute trauma or fracture. Following recent surgical procedures when muscle contraction may disrupt the healing process. Over areas of the skin that lack normal sensation. If you have suspected or diagnosed epilepsy. Some patients may experience a skin irritation, an allergic reaction, or hypersensitivity to the electrical stimulation or the electrical conductive medium. Irritation may be avoided by having your clinician change the stimulation parameters, type of electrodes, or electrode placement. Do not use the NESS L300 without electrodes. After removing the FS Cuff, it is normal for the areas under the electrodes to be red and indented. The redness should disappear in approximately one hour. Persistent redness, lesions, or blisters are signs of irritation. Alert 4 User s Guide

13 your clinician and stop using the NESS L300 until any inflammation is gone. Stop using the NESS L300 and consult your clinician if stimulation does not start at the correct time during gait. Do not wear the NESS L300 during x-ray examinations. Turn off the NESS L300 when at a refueling place. Do not use the NESS L300 near flammable fuel, fumes, or chemicals. Only your treating clinician should determine electrode placement and stimulation settings. Use only NESS L300 electrodes supplied by Bioness Inc. Obtain physician clearance prior to use if you have an alteration in normal arterial or venous flow in the region of the FS Cuff because of local insufficiency, occlusion, arteriovenous fistula for hemodialysis, or a primary disorder of the vasculature. Obtain physician clearance before stimulating an area with a structural deformity. The safe use of the NESS L300 during pregnancy has not been established. Skin problems where the FS Cuff is worn may be aggravated by the NESS L300. Turn off the NESS L300 before removing or replacing the electrodes. Adult supervision and assistance should be provided for anyone needing help while using the NESS L300 system. Protect all electronic components from contact with water, such as from sinks, bathtubs, shower stalls, rain, snow, etc. Do not leave the NESS L300 stored where temperatures may exceed the acceptable environmental range: -20 C to +60 C (-4 F to +140 F). Temperature extremes can damage the components. Do not attempt to repair your NESS L300. Contact Bioness if you experience Chapter 2 - Health and Safety Information 5

14 a technical problem not covered in this guide. The FS Cuff is to be worn only on the leg of the patient for whom it is fitted. It should not be worn by anyone else or on any other part of the body. Turn off the NESS L300 before putting on the FS Cuff. Do not turn on the NESS L300 until the FS Cuff is fastened in place. Shut off the NESS L300 before driving, operating machinery, or performing any activity in which involuntary muscle contractions could injure you. Protect the NESS L300 electronic components from condensation. When moving the components between hot and cold temperatures, place them in an airtight plastic bag, and let them slowly (for at least two hours) adjust to the temperature change before use. Medical electrical equipment needs special precautions for electromagnetic compatibility. Adverse Reactions In the unlikely event that any of the following occurs, stop using your NESS L300 immediately and consult your physician. Signs of significant irritation or pressure sores where the FS Cuff contacts the skin. A significant increase in muscle spasticity. A feeling of heart-related stress during stimulation. Swelling of the leg, knee, ankle, or foot. Any other unanticipated reaction. Skin irritations and burns have been reported with the use of powered muscle stimulators. 6 User s Guide

15 Skin Care Guidelines In the absence of proper skin care, extended use of electrical stimulation may cause skin irritation or a skin reaction to the electrodes or the FS Cuff. Skin irritation tends to occur after approximately three months of use. To promote healthy skin with long-term use of the NESS L300, it is important to follow a daily skin-care routine. Clean the skin where the electrodes adhere with a wet washcloth. If any oils or lotions are on the skin, then clean with soap and water. Rinse well. Always check the skin for redness or a rash when putting on and taking off the FS Cuff. Replace the electrodes at least every two weeks, even if they appear to be in good condition. After taking off the FS Cuff, always re-cover hydrogel electrodes with the protective plastic covers, where applicable. Excess body hair where the electrodes adhere may reduce electrode contact with the skin. If necessary, remove excess body hair with an electric shaver or scissors. Do not use a razor. A razor can irritate the skin. When positioning the FS Cuff, make sure the electrodes uniformly contact the skin. Ventilate the skin by removing the FS Cuff for at least 15 minutes every three to four hours. If skin irritation or a skin reaction occurs, stop using your NESS L300 immediately. Contact your clinician, dermatologist, or Bioness Clinical Specialist. Resume use only when the skin is completely healed, and then follow a skin conditioning protocol per the recommendation of your health-care specialist. Chapter 2 - Health and Safety Information 7

16 Caution: Do not put on or operate the NESS L300 before being properly fitted and trained by a certified clinician. Caution: The Intelli-Sense Gait Sensor has not been validated for use by individuals weighing more than 136 kilograms (300 pounds). Caution: Do not use the Intelli-Sense Gait Sensor with a rigid insole, such as a custom rigid orthosis or an ankle foot orthosis. Caution: Use only NESS L300 electrodes supplied by Bioness Inc. Do not use the NESS L300 without electrodes. Caution: Change the electrodes every two weeks. Caution: Changes or modifications to the NESS L300 not expressly approved by Bioness Inc could void the user's authority to operate the equipment. Caution: Use only the charger included in your NESS L300 System Kit. Use of any other charger could damage the system. Caution: The control unit neck strap is meant to be worn around the neck and if not used properly could cause bodily harm. If you have any questions or concerns, please telephone the NESS L300 Technical and Clinical Support Department at (800) , Option 3. 8 User s Guide

17 Environmental Conditions that Affect Use 3 Radio Frequency (RF) Communication Several components of the NESS L300 communicate via radio communication and have been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 (RF Devices) of the FCC (Federal Communications Commission) Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate RF energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Consult the dealer or an experienced radio/tv technician for assistance. The antenna for each transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. Portable and mobile RF communications equipment can affect the NESS L300 System. Chapter 3 - Environmental Conditions that Affect Use 9

18 Conformity Certification The NESS L300 System complies with Part 15 of the FCC rules. Operation is subject to the following two conditions: 1. This device may not cause harmful interference, and 2. This device must accept any interference received, including interference that may cause undesired operation. Travel The NESS L300 System charger set with interchangeable blades is compatible with both European and U.S. voltage: 110/220 V, 50/60 Hz. Turn off your L300 system before going through airport security. Wear loose clothing so that you can easily show the security person your NESS L300. The NESS L300 will likely set off the security alarm. Either ask for a hand scan or be prepared to remove your NESS L300 so that security can scan it. You may want to carry a copy of your NESS L300 prescription. A prescription can be useful when passing through customs as well. To request a copy of your prescription, call Bioness Customer Support: telephone: (800) , Option 2; or (661) , Option 2. A Bioness representative can fax or mail you a copy. Note: The NESS L300 contains radio transmitters. The Federal Aviation Administration (FAA) rules require that all radio-transmitting devices be turned off during flight. 10 User s Guide

19 Electromagnetic Emissions The NESS L300 System needs special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in this manual. The NESS L300 System was tested and certified to use the following: DC power supply as provided by Bioness Inc, manufactured by Friwo, Part No. FW7555M/05. "Y" cable (2-way splitter) as provided by Bioness Inc. Manufactured by Tamuz Electronics Ltd. Warnings The use of accessories, transducers, and cables other than those specified, with the exception of transducers and cables sold by the manufacturer of the NESS L300 System as replacement parts for internal components, may result in increased emissions or decreased immunity of the NESS L300 System. The NESS L300 System should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the equipment or system should be observed to verify normal operation in the configuration in which it will be used. The use of the accessory, transducer, or cable with equipment and systems other than those specified may result in increased emissions or decreased immunity of the NESS L300 System. Chapter 3 - Environmental Conditions that Affect Use 11

20 The NESS L300 System may be interfered with by other equipment, even if that other equipment complies with CISPR (International Special Committee on Radio Interference, International Electrotechnical Commission (IEC)) emission requirements. 12 User s Guide

21 NESS L300 System Kit Your Small NESS L300 System Kit includes the following: 4 Small L300 FS Cuff, Right or Left, with (XS) Strap L300 RF Stim Unit Intelli-Sense Gait Sensor Control Unit System Charger Set Small L300 FS Cuff Strap (XXS) Gait Sensor Pads Shoe Spacers Gait Sensor Replacement Battery Small Electrode Bases Cloth Electrode Mesh Bag Control Unit Neck Strap Control Unit Wrist Strap Control Unit Belt Pouch Phillips Screwdriver User s Guide User's Reference Card Chapter 4 - NESS L300 System Kit 13

22 Your Regular NESS L300 System Kit includes the following: Regular L300 FS Cuff, Right or Left, with (M) Strap L300 RF Stim Unit Intelli-Sense Gait Sensor Control Unit System Charger Set Regular L300 FS Cuff Strap (S) Regular L300 FS Cuff Strap (L) Gait Sensor Pads Shoe Spacers Gait Sensor Replacement Battery Cloth Electrode Mesh Bag Control Unit Neck Strap Control Unit Wrist Strap Control Unit Belt Pouch Phillips Screwdriver User s Guide User's Reference Card 14 User s Guide

23 Regular L300 FS Cuff and RF Stim Unit Small L300 FS Cuff and RF Stim Unit Intelli-Sense Gait Sensor Control Unit System Charger Set Regular FS Cuff Strap (S, M, L) Small FS Cuff Strap (XXS, XS) Chapter 4 - NESS L300 System Kit 15

24 Gait Sensor Pads Shoe Spacers Phillips Screwdriver Cloth Electrode Mesh Bag Gait Sensor Replacement Battery Small Electrode Bases (only in the Small NESS L300 System Kit) Control Unit Neck Strap Control Unit Wrist Strap Control Unit Belt Pouch 16 User s Guide

25 NESS L300 System Components 5 Functional Stimulation (FS) Cuff Your L300 FS Cuff (see figure 5-1) is lightweight and easily fits under most clothing. It features a cradle for the RF Stim Unit and an anatomically designed locator for accurate placement on your leg. It also features a strap that can be fastened with one hand. Electrode Electrode Base Liner Liner Locator Locator Strap Strap Handle Cradle Strap Handle RF Stim Unit Regular L300 FS Cuff Small L300 FS Cuff Figure 5-1: Regular L300 FS Cuff and Small L300 FS Cuff. Chapter 5 - NESS L300 System Components 17

26 Electrodes and Electrode Bases There are three types of electrodes that can be used with the L300 FS Cuff to deliver stimulation. With a Small NESS L300 System the following electrodes and electrode bases can be used (See Figure 5-2): Small L300 Quick Fit Electrode - Size A or B (as fitted by your clinician) Small L300 Cloth Electrodes Small L300 Electrode Bases (used with the Small L300 Cloth Electrodes) Small L300 Quick Fit Electrode - A Small L300 Quick Fit Electrode - B Small L300 Cloth Electrodes Small L300 Electrode Bases Figure 5-2: Electrodes and Bases for the Small L300 FS Cuff. 18 User s Guide

27 With a Regular NESS L300 System the following electrodes and electrode bases can be used (See Figure 5-3): Regular L300 Quick Fit Electrode, left - A or right - A Regular L300 Cloth Electrodes Regular L300 Cloth Electrode Bases Regular L300 Hydrogel Electrodes Regular L300 Hydrogel Electrode Bases Regular L300 Cloth Electrodes Regular L300 Cloth Electrode Bases Regular L300 Quick Fit Electrode (right - A shown) Regular L300 Hydrogel Electrodes Regular L300 Hydrogel Electrode Bases Figure 5-3: Electrodes and Bases for the Regular L300 FS Cuff. Your clinician will fit you with the appropriate electrode option and attach them to your L300 FS Cuff. Afterward, you will need to replace the electrodes every two weeks. Chapter 5 - NESS L300 System Components 19

28 RF Stim Unit The RF Stim Unit fits into the cradle of the L300 FS Cuff. See Figure 5-1. It responds to signals from the Control Unit and Intelli-Sense Gait Sensor to turn stimulation on/off. It has a rechargeable battery, a status light, and a stimulation light. See Table 5-1. The RF Stim Unit emits an audio alert when radio communication fails or the component malfunctions. Remove the RF Stim Unit when cleaning the FS Cuff and for maintenance. RF Stim Unit Display Description Definition Status Light Stimulation Light Flashes GREEN Flashes YELLOW Alternately Flashes YELLOW and GREEN Solid GREEN Flashes RED Solid RED Flashes YELLOW SLOWLY Flashes YELLOW RAPIDLY System is On Low Battery Battery Charging Battery Fully Charged Radio Communication Failure RF Stim Unit Malfunction Stimulation is Off Stimulation is On Table 5-1: RF Stim Unit displays and definitions. 20 User s Guide

29 Intelli-Sense Gait Sensor The Intelli-Sense Gait Sensor detects when your foot is in the air and on the ground, and wirelessly signals the other NESS L300 components to move your foot accordingly. The Intelli-Sense Gait Sensor features a pressure sensor and a transmitter. The pressure sensor fits under the insole of the shoe of your weak foot, attached to a Gait Sensor pad. See Figure 5-4. The transmitter is worn clamped to the inner rim of your shoe. (Shoe spacers are provided to protect the shoe from damage from the clamp.) The Intelli-Sense Gait Sensor can be transferred to a different shoe, or additional sensors can be purchased for different shoes. You do not need to detach the Intelli-Sense Gait Sensor between uses. The Intelli-Sense Gait Sensor is powered by a small non-rechargeable battery. The battery will need to be replaced after approximately six months of use. A Phillips screwdriver is provided for changing the battery. Caution: The Gait Sensor has not been validated for use by individuals weighing more than 136 kilograms (300 pounds). Transmitter Shoe Insole Clamp Pressure Sensor Gait Sensor Pad Figure 5-4: Intelli-Sense Gait Sensor. Chapter 5 - NESS L300 System Components 21

30 Control Unit The Control Unit is used to turn on/off the system, select an operating mode (gait, training, standby, or clinician), fine-tune stimulation intensity, adjust audio alert volume, and monitor system performance. See Figure 5-5. The Control Unit communicates wirelessly with the RF Stim Unit and Intelli-Sense Gait Sensor. It is powered by a single rechargeable AAA battery. Your NESS L300 System Kit includes a system charger set for charging the Control Unit and RF Stim Unit. It also includes a belt pouch, wrist strap, and neck strap for carrying the Control Unit. A Phillips screwdriver is provided for changing the Control Unit battery. Loop Hole for Wrist and Neck Straps On/Off Button Volume Buttons Control Unit Indicator Mode Button Intensity Adjustment (Plus/Minus) Buttons RF Stim Unit Indicator Intelli-Sense Gait Sensor Indicator Digital Display Figure 5-5: Control Unit operating buttons, indicators, and digital display. 22 User s Guide

31 Control Unit Operating Buttons The Control Unit operating buttons and their functions are described in Table 5-2. Control Unit Operating Button Description Function On/Off Turns On/Off the Control Unit Mode Selects Standby, Gait, Training, or Clinician Mode Volume Adjusts Volume of Audio Alerts and Turns On/Off Audio Feedback for Stimulation Intensity Adjustment (Plus/Minus) Adjusts Stimulation Intensity Level Table 5-2: Control Unit operating buttons and functions. Chapter 5 - NESS L300 System Components 23

32 Control Unit Operating Modes The Control Unit has four operating modes: standby, gait, training, and clinician. Only clinicians use clinician mode. Standby Mode In standby mode, the NESS L300 System is on and waiting for commands. Stimulation is off. Gait Mode Gait mode is used when walking. In gait mode, the Gait Sensor signals the RF Stim Unit when your heel or forefoot leaves the ground, turning stimulation on. It also signals when your heel or forefoot contacts the ground, turning stimulation off. Training Mode Training mode is used to train muscles when you are not walking (for example, sitting or lying down). Training mode should not be used when walking. Training mode works independently of the Intelli-Sense Gait Sensor. Stimulation is delivered in cycles pre-set by your clinician. Training mode is designed to facilitate muscle re-education, prevent or retard disuse atrophy of the lower leg muscles, maintain or improve range of motion of the ankle joint, and improve local blood circulation. Training mode also can be used to check if the FS Cuff is positioned properly. If your foot does not respond to the stimulation as it should, reposition the FS Cuff. Control Unit Digital Display and Indicator Lights The Control Unit digital display and indicator lights indicate stimulation intensity level, operating mode, battery charge status, electronic registration status, and error messages. See tables 5-3 and User s Guide

33 Control Unit Display Description Definition On/Off Button Flashes GREEN Mode Button Flashes YELLOW SLOWLY Mode Button Flashes YELLOW RAPIDLY Displays 0 9 Intensity Level and t Alternate in the Digital Display A Component Indicator Flashes YELLOW Rotating GREEN Circle Horizontal GREEN Line System is On System is in Gait/ Training/Clinician Mode, Stimulation is Off System is in Gait/ Training/Clinician Mode, Stimulation is On Intensity Level Training Mode Component Low Battery Control Unit Charging Control Unit Fully Charged Table 5-3: Control Unit visual displays and definitions. Chapter 5 - NESS L300 System Components 25

34 Control Unit Display Description Definition RF Stim Unit Indicator Flashes RED and Intensity Level Flashes Faulty Electrode Contact Control Unit and RF Stim Unit Indicators Alternately Flash RED and E Flashes Gait Sensor and RF Stim Unit Indicators Alternately Flash RED and E Flashes A Component Indicator is Solid RED and E Appears Radio Communication Failure Between the Control Unit and RF Stim Unit Gait Sensor Hibernation or Radio Communication Failure between the Gait Sensor and RF Stim Unit Component Malfunction Table 5-4: Control Unit error displays and definitions. Control Unit Audio Indicators The Control Unit beeps to indicate: The system is on. A button was pressed. Low battery. An error (usually accompanied by a visual indicator). 26 User s Guide

35 Setting Up the NESS L300 System 6 Positioning the L300 FS Cuff To position the L300 FS Cuff: 1. Clean the skin where the electrodes will touch with a wet washcloth. If any oils or lotions are on the skin, clean the skin with soap and water. Rinse well. 2. If necessary, trim excess body hair from the area using scissors. Do not use a razor. A razor can irritate the skin. 3. While seated, slightly straighten your leg as shown in Figure 6-1. The outline of your kneecap should be clearly defined. (Place your foot on a footrest, if necessary.) The Locator of the FS Cuff Fits Under the Kneecap Figure 6-1: Recommended knee angle for positioning the L300 FS Cuff. Chapter 6 - Setting Up the NESS L300 System 27

36 4. Make sure the electrodes are securely attached. Then, grasp the front of the L300 FS Cuff by the cradle and tilt the bottom of the FS Cuff up. Slide the locator up your leg until it rests snugly and comfortably below your kneecap. See Figure 6-2. Locator Hook and Loop Fasteners Strap Handle Figure 6-2: Tilting the L300 FS Cuff for placement on your leg. 5. Hold the locator in place and lower the L300 FS Cuff until it rests flush against your leg. 6. Grasp the handle of the L300 FS Cuff strap. See Figure 6-3. With your thumb on the FS Cuff cradle, fasten the strap handle around the cradle. With the Small L300 FS Cuff you may need to use your other hand to stabilize the cuff on the leg. 7. Make sure the L300 FS Cuff is correctly positioned. See Figure 6-4. If it is not, take off the FS Cuff and reposition it. Adjust the hook and loop fasteners (see Figure 6-2) to ensure a snug fit. 28 User s Guide

37 Locator Below the Kneecap Thumb on Cradle and Fingers on Strap Handle Regular L300 FS Cuff Small L300 FS Cuff Figure 6-3: Fastening the L300 FS Cuff strap. Locator Below the Kneecap RF Stim Unit Strap Handle Around the Cradle Regular L300 FS Cuff Small L300 FS Cuff Figure 6-4: L300 FS Cuff fastened on the right leg. Chapter 6 - Setting Up the NESS L300 System 29

38 Removing the L300 FS Cuff To remove the L300 FS Cuff: 1. Turn off the Control Unit. 2. Unhook the L300 FS Cuff strap handle from the cradle. 3. Slowly lift the L300 FS Cuff away from your skin. 4. If using hydrogel electrodes (Regular L300 FS Cuff users only) gently peel the electrodes from your skin, and reapply the electrode covers to the electrodes. 5. Fully charge the Control Unit and RF Stim Unit batteries. Note: Remove the L300 FS Cuff several times daily, to allow the skin below the FS Cuff to breathe. Caution: Change the electrodes every two weeks. 30 User s Guide

39 Positioning the Intelli-Sense Gait Sensor The Intelli-Sense Gait Sensor pressure sensor is placed under the insole of your shoe. If your shoe does not have a detachable insole, place the sensor on top of the insole. Then, place a generic soft, thin (one layer versus two) insole over it. Generic insoles can be purchased from drugstores, shoe stores, or Bioness. Caution: Do not use the Gait Sensor with a rigid insole, such as a custom rigid orthosis or an ankle foot orthosis. To position the Intelli-Sense Gait Sensor: 1. Lift the shoe insole. 2. Attach a Gait Sensor pad under the insole, in the position that was defined by your clinician. See Figure 6-5. Shoe Insole Gait Sensor Pad Heel Position Gait Sensor Pad Forefoot Position Figure 6-5: Placement of the Gait Sensor pad. Chapter 6 - Setting Up the NESS L300 System 31

40 3. For heel position placement point the wire of the Intelli-Sense Gait Sensor toward the toe of the shoe. For forefoot position placement point the wire of the Intelli-Sense Gait Sensor toward the heel of the shoe. Then, attach the pressure sensor to the Gait Sensor pad. See Figure 6-6. Refer to the foot image on the pressure sensor for positioning. Note: The image of the foot on the gait sensor pad will be reverse when in the forefoot position. Gait Sensor Pad Forefoot Placement Heel Placement Figure 6-6: Positioning the Gait Sensor in the shoe. 4. Cover the clamp on the transmitter with the shoe spacer, if desired. See Figure 6-7. The teeth of the clamp may scuff the shoe, if not covered. Shoe Spacer Teeth Figure 6-7: Covering the clamp with the shoe spacer. 32 User s Guide

41 5. Clamp the Gait Sensor transmitter on to the inner rim of the shoe. Face the NESS logo on the transmitter away from the ankle. See Figure 6-8. NESS Logo Faces away from Ankle Transmitter Clamp to Inner Rim of Shoe Pressure Sensor Figure 6-8: Clamping the transmitter to the inner rim of the shoe. (Gait sensor in the heel position in a left shoe shown.) 6. Cover the pressure sensor with the insole. Tuck any excess wire under the insole. See Figure 6-9. Heel Position Forefoot Position Figure 6-9: Insole covering the pressure sensor and wire. (Left shoe shown.) Chapter 6 - Setting Up the NESS L300 System 33

42 Switching Shoes/Gait Sensors When switching the Intelli-Sense Gait Sensor to a different shoe, make sure to place a Gait Sensor pad in the other shoe first. If multiple Gait Sensors are placed in multiple shoes and you want to switch shoes: 1. Turn off the system. 2. Switch shoes. 3. Turn the system back on. 34 User s Guide

43 Operating the NESS L300 System RF Communication Safety Features The Control Unit, RF Stim Unit, and Intelli-Sense Gait Sensor must be within RF communication range of each other and their batteries charged for the NESS L300 System to operate. If the components become separated, or if a battery is discharged, RF communication will be lost and the system will stop working until RF communication is restored. 7 If RF communication fails: The Control Unit and RF Stim Unit indicators will flash RED and E will flash in the digital display. The Control Unit will emit an audio alert. The NESS L300 will deliver a warning default stimulation to lift the foot for six seconds before shutting down. Operating the Control Unit Turning On/Off the Control Unit To turn on the Control Unit, press the on/off button once. The system will start in standby mode. All display indicators will light up for a few seconds while the system performs a self-test. The on/off button will flash GREEN to indicate the system is on. To turn off the Control Unit, press the on/off button once. Chapter 7 - Operating the NESS L300 35

44 Selecting an Operating Mode Gait Mode. To select gait mode, turn on the Control Unit, and press the mode button briefly. The Control Unit will beep and the mode button will start flashing YELLOW SLOWLY (indicating that stimulation is off). When stimulation is on, the mode button will flash YELLOW RAPIDLY. Training Mode. To select training mode, turn on the Control Unit. Press and hold the mode button until the Control Unit beeps, the mode button starts flashing YELLOW SLOWLY (indicating that stimulation is off), and ( t for training) alternates with the intensity level in the digital display. When stimulation is on, the mode button will flash YELLOW RAPIDLY. Standby Mode. To return to standby mode from gait or training mode, press the flashing mode button briefly. The Control Unit will beep, and the mode button will stop flashing. 36 User s Guide

45 Adjusting Stimulation Intensity When the Control Unit is first turned on, the stimulation intensity level will be 5. This level is set by your clinician. Normally, you will not need to adjust stimulation intensity other than when walking on different surfaces or in different shoes. To adjust stimulation intensity, press the plus or minus intensity adjustment button on the Control Unit. The Control Unit will beep with each change in level. The new level will show in the digital display. Note: An intensity level of 0 equals no stimulation. If your foot slightly drags or catches on the floor while walking, increase stimulation intensity to lift the foot higher. If your foot rises too high while walking or if stimulation is unpleasant, decrease stimulation intensity. Be sure your foot does not drag or catch on the floor after decreasing the intensity level. Adjusting the Volume of Audio Alerts Use the volume buttons to adjust the volume of the audio alerts. Each time one of the buttons is pressed, the volume level will change. The Control Unit will beep to demonstrate the new volume. To mute the audio alerts, lower the volume to the lowest setting. When the system is turned off, the active volume level is saved. If the active volume level is mute, the default volume level is automatically restored. Chapter 7 - Operating the NESS L300 37

46 Turning On Audio Feedback During Stimulation You can choose to receive an audio alert when stimulation turns on. To turn on Audio Feedback, turn on the Control Unit and press and hold the up volume button for three seconds. To turn off Audio Feedback, press the off the Control Unit. down volume adjust button or turn 38 User s Guide

47 Maintenance and Cleaning 8 Charging the Batteries When a system component has a low battery, the Control Unit will beep and the component indicator light will flash YELLOW. See Table 8-1. When the RF Stim Unit battery is low, the RF Stim Unit status light will also flash YELLOW. When the Intelli-Sense Gait Sensor battery is low, the Control Unit low-battery audio alert will become more persistent as the battery weakens. Display Definition Low Battery: Control Unit Flashing YELLOW Low Battery: RF Stim Unit Flashing YELLOW Flashing YELLOW Low Battery: Intelli-Sense Gait Sensor Table 8-1: Low battery displays and definitions. Chapter 8 - Maintenance and Cleaning 39

48 To charge the batteries in the Control Unit and RF Stim Unit: 1. Open and assemble the System Charger Set. The System Charger set comes with four interchangeable blades for U.S. and international outlets. Select the appropriate blade that fits the chosen power outlet and slide the blade onto the end of the charger. Then connect the "Y" cable to the charger cable. 2. Open the cover of the charging ports (found at the bottom of the Control Unit and at the top of the RF Stim Unit). See Figure 8-1. Cover RF Stim Unit Charging Port Control Unit Charging Port Cover Figure 8-1: RF Stim Unit and Control Unit charging ports (L300 Regular FS Cuff shown). Caution: The batteries must be charged before first use, daily, and after extended storage. Caution: Only the Control Unit and RF Stim Unit batteries are rechargeable. Caution: Remove the FS Cuff before charging the batteries. 40 User s Guide

49 Caution: Do not use the RF Stim Unit or Control Unit while charging. Caution: Use only the charger included in your NESS L300 System Kit. Use of any other charger could damage the system. 3. Connect the system charger set to the Control Unit and RF Stim Unit. See Figure 8-2. System Charger Set Figure 8-2: Charging set-up. (L300 Regular FS Cuff shown). 4. Plug the system charger set into a wall socket. 5. Verify that the rotating GREEN circle appears in the Control Unit digital display, and the status light on the RF Stim Unit is alternately flashing YELLOW and GREEN. See figures 8-3 and 8-4. Chapter 8 - Maintenance and Cleaning 41

50 Note: It is possible to charge the Control Unit and RF Stim Unit separately, but Bioness recommends that the Control Unit and RF Stim Unit be charged at the same time. 6. The charging process will continue until a horizontal GREEN line appears in the Control Unit digital display and the RF Stim Unit status light is solid GREEN. See figures 8-3 and 8-4. The charging process should last approximately three hours. The Control Unit and RF Stim Unit can remain connected to the charger after charging is complete. Note: If the Control Unit battery is completely discharged, a b (for boot) will flash for a few seconds in the Control Unit digital display when charging is started. Rotating GREEN Circle: Control Unit Charging Horizontal GREEN Line: Control Unit Fully Charged Figure 8-3: Control Unit charging displays. Status Light Alternately Flashing GREEN and YEL- LOW: RF Stim Unit Charging Status Light Solid GREEN: RF Stim Unit Fully Charged Figure 8-4: RF Stim Unit charging displays. 42 User s Guide

51 Replacing the Batteries RF Stim Unit Battery The RF Stim Unit rechargeable battery should be replaced approximately every two years by a Bioness certified technician. Intelli-Sense Gait Sensor Battery The battery in the Intelli-Sense Gait Sensor is not rechargeable. It should be replaced approximately every six months. The Gait Sensor indicator on the Control Unit will begin to flash YELLOW approximately two weeks before the Gait Sensor completely loses its charge. The Control Unit will also emit an alarm. To install a new Gait Sensor battery (Lithium coin cell, CR2430): 1. Use the Phillips screwdriver supplied in the system kit to unscrew the two screws from the battery cover. See Figure 8-5. Screws Cover Battery Figure 8-5: Replacing the Gait Sensor battery. Chapter 8 - Maintenance and Cleaning 43

52 2. Slide the cover out. 3. Note the + orientation of the old battery. 4. Remove the old battery and properly dispose of it according to your local environmental regulations. 5. Insert the new battery. The + should face outward. 6. Slide the cover back into place, and tighten the screws. 7. Press the Gait Sensor pressure sensor to activate the sensor. Remove the old battery, and properly dispose of it according to your local environmental regulations. Control Unit Battery The battery in the Control Unit is a rechargeable AAA battery. It should be replaced approximately every two years. To install a new Control Unit battery (AAA NiMH 1.2 V): 1. Remove the screw from the battery cover on the back of the Control Unit. See Figure 8-6. (The screw may be under a small label. If so, gently peel off one end of the label. Reapply the label after the battery is replaced.) 2. Remove the battery cover. 3. Note the "+/-" orientation of the old battery. 44 User s Guide

53 4. Insert the new rechargeable battery in the proper "+/-" orientation. 5. Slide the cover into place, and tighten the screw. 6. Fully charge the new battery before first use. Caution: Use of a non-rechargeable AAA battery can damage the Control Unit. Battery Battery Cover Screw Control Unit Figure 8-6: Replacing the Control Unit battery. Remove the old battery, and properly dispose of it according to your local environmental regulations. Chapter 8 - Maintenance and Cleaning 45

54 Replacing the L300 Quick Fit Electrodes You will need to replace the L300 Quick Fit Electrodes at least every two weeks. Caution: Use only L300 electrodes supplied by Bioness. Caution: Do not use your NESS L300 system without electrodes. Caution: Do not fold or twist the L300 Quick Fit Electrode. To replace the L300 Quick Fit Electrodes: (See Figure 8-7) 1. Turn off the Control Unit and remove the L300 FS Cuff. 2. Gently remove the used L300 Quick Fit Electrode from the L300 FS Cuff. 3. Wet the entire new L300 Quick Fit Electrode with water. 4. Remove excess water from the L300 Quick Fit Electrode with a cloth. 5. Align the orange and blue snaps on the L300 Quick Fit Electrode with the orange and blue plug holes on the L300 FS Cuff. 6. Press firmly to snap the L300 Quick Fit Electrode into the L300 FS Cuff. Note: Remove and re-wet the entire L300 Quick Fit Electrode every time you remove the L300 FS Cuff from your leg for more than one hour, and after every three to four hours of use. When wetting the L300 Quick Fit Electrode, always remove it from the L300 FS Cuff. Note: Store the L300 Quick Fit Electrode where it can air dry, when not in use. 46 User s Guide

55 2 3 Orange and Blue Plug Holes Figure 8-7: Replacing the L300 Quick Fit Electrode. (Regular L300 Quick Fit Electrode and Regular L300 FS Cuff shown.) Chapter 8 - Maintenance and Cleaning 47

56 Replacing the Cloth Electrodes First fittings will be done by your clinician. Afterward, you will need to change the cloth electrodes at least every two weeks and the cloth electrode bases every year. Caution: Use only L300 cloth electrodes supplied by Bioness. Caution: Do not use your NESS L300 system without electrodes. To replace the L300 Cloth Electrodes: (See Figure 8-8) 1. Turn off the Control Unit and remove the L300 FS Cuff.. 2. Gently pull the used cloth electrodes from the cloth electrode bases. Be careful not to detach the electrode bases from the L300 FS Cuff. 3. If necessary, clean the electrode bases with a damp cloth. Do not use a chemical-based cleaning substance. 4. Wet the new cloth electrodes with water until they are saturated. 5. With a soft cloth, gently wipe or blot excess water off the back (side with the snap) of the cloth electrodes. 6. Attach the cloth electrodes to the electrode bases. Note: Remove and re-wet the cloth electrodes every time you remove the L300 FS Cuff from your leg for more than one hour, and after every four hours of use. When wetting the cloth electrodes, always remove them from the FS Cuff. If the cloth electrodes dry out, your response to the stimulation may change. If you need to adjust stimulation intensity more often than usual, try re-wetting the cloth electrodes following the steps listed above. 48 User s Guide

57 Note: Store the L300 Cloth Electrodes, when not in use in the Cloth Electrode Mesh Bag or in a location where they can air dry Figure 8-8: Replacing the L300 Cloth Electrodes. (Regular L300 Cloth Electrodes and Regular L300 FS Cuff shown.) Chapter 8 - Maintenance and Cleaning 49

58 Replacing the Hydrogel Electrodes For Regular L300 FS Cuff users the Regular L300 Hydrogel Electrodes are one of the electrode options for home use. You will need to replace the hydrogel electrodes at least every two weeks. Caution: Use only L300 hydrogel electrodes supplied by Bioness. Caution: Do not use your NESS L300 System without electrodes. To replace the L300 Hydrogel Electrodes: (See Figure 8-9) 1. Turn off the Control Unit and remove the L300 FS Cuff.. 2. Gently pull the used electrodes from the electrode bases. Be careful not to detach the electrode bases from the L300 FS Cuff. 3. If necessary, clean the electrode bases with a damp cloth. Do not use a chemical-based cleaning substance. 4. Separate the two new electrodes along the perforation. 5. Split the two-piece covers on each new electrode and discard them. 6. Attach the grid side of the electrodes to the electrode bases, and then press firmly. 7. Remove the covers from the electrodes. 50 User s Guide

59 Note: Save the covers. Always reapply the covers between uses. When reapplying the covers, make sure the Bioness logo faces up. Note: If the electrode gel becomes dry, rehydrate it with one to two drops of water Figure 8-9: Replacing the L300 Hydrogel Electrodes. (Regular L300 Hydrogel Electrodes and Regular L300 FS Cuff shown.) Chapter 8 - Maintenance and Cleaning 51

60 Replacing the Electrode Bases You will need to replace the electrode bases after one year of use. Contact Bioness to purchase replacement electrode bases. For Regular L300 FS Cuff users, if you are switching from hydrogel to cloth electrodes, or from cloth electrodes to hydrogel electrodes, you will need to be seen by a qualified clinician for a first fitting. Your clinician will need to fit the electrode bases and adjust your stimulation settings. To replace the electrode bases: (See Figure 8-10) 1. If your clinician installed wire concealers over the electrode base wires, remove the wire concealers. 2. Mark the position of the used electrode bases on the FS Cuff liner with a permanent marker. 3. Disconnect the electrode base snaps from the plug holes. 4. Remove the used electrode bases from the L300 FS Cuff. 5. Attach the new electrode bases where the previous bases were attached. 6. Connect the electrode base snaps to the plug holes. 7. Recover the wires and snaps with the wire concealers, if desired. 52 User s Guide

61 Plug Hole Figure 8-10: Replacing the L300 Electrode Bases. (Regular L300 FS Cuff shown.) Chapter 8 - Maintenance and Cleaning 53

62 Removing the RF Stim Unit The only time you should remove the RF Stim Unit is to clean the FS Cuff or replace the RF Stim Unit. To remove the RF Stim Unit: 1. Turn off the Control Unit. 2. Pull the top of the RF Stim Unit away from the cradle. See Figure If the fit is too tight, open the flexible cover over the charging port for a better grasp. 3. Remove the bottom of the RF Stim Unit from the cradle. Cradle Inserting the RF Stim Unit To insert the RF Stim Unit: RF Stim Unit Figure 8-11: Removing the RF Stim Unit. 1. Insert the bottom of the RF Stim Unit into the cradle. Then, gently push the top of the RF Stim Unit into the cradle until it snaps in. 54 User s Guide

63 Cleaning Your NESS L300 Components All NESS L300 components may be cleaned by carefully wiping them with a damp cloth. The electrical components are not waterproof. Do not immerse them in water. The L300 FS Cuff is the only component that can be immersed in water to clean. Bioness recommends cleaning the L300 FS Cuff when replacing the electrodes. To clean the L300 FS Cuff: 1. Remove the RF Stim Unit. 2. Gently remove the electrodes from the electrode bases. For hydrogel electrodes, re-apply the electrode covers. Do not remove the electrode bases. 3. Immerse the L300 FS Cuff for 30 minutes in lukewarm water and mild detergent. Do not use a washing machine. 4. Rinse the L300 FS Cuff thoroughly under running water. 5. Immerse the L300 FS Cuff for an additional 15 minutes in clean, lukewarm water. 6. Rinse the L300 FS Cuff again under running water. 7. Gently blot excess moisture from the L300 FS Cuff with a towel. Do not wring the FS Cuff. Lay the FS Cuff flat in the shade to dry. (Do not hang dry.) Drying time will vary from 4 to 12 hours depending on climate and humidity. For faster drying, place the FS Cuff in front of a circulating coldair fan. Do not use a hot-air dryer or other heat source to dry. 8. When the L300 FS Cuff is completely dry, insert the RF Stim Unit and attach the electrodes. Chapter 8 - Maintenance and Cleaning 55